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Understand, implement, maintain, and continually improve the effectiveness the Baxter Quality Management System for the plant.  Assure systems, processes, and procedures for regulatory compliance are established and deployed.  Ensure compliance to applicable standards and regulations.  Manage regulatory inspections.  Serve as back up to the Quality Management Representative for the plant.

Essential Duties and Responsibilities.  This section contains a list of five to eight primary responsibilities of the work.  The incumbent will perform other duties as assigned.

• Establish and maintains the Quality Management System under the umbrella of Baxter’s quality system adapted for the Opelika plant.
• Takes a leading role in promoting and participating in cross-functional teams especially with regard to QSR requirements and quality issues.
• Lead’s the plant’s CAPA, Change Control, Training and Complaint systems. Coordination of risk assessments as required.
• Assures departments are fully trained in all aspects of their positions.
• Ensures that departments under this responsibility execute work in accordance with established procedures
• Leads the in the internal and external audit program.
• Supports the regulatory documentation for licensing
• Support Supplier Quality and Material Control activities
• Must be able to remain in a stationary position.

Physical Requirements:  Physical requirements for a position will vary.  These must be reviewed with the supervisor and should be attached here.

• The person in this position needs to occasionally enter the clean room, into the production environment.
• Constantly operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer.
• The person in this position frequently communicates with internal and/or external contacts.  Must be able to exchange accurate information in these situations.
• Duties may require overtime work, including nights and weekends.
• Requires standing, walking, lifting up to 25 lbs., bending, pulling, pushing, and climbing stairs.

Qualifications.  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  List knowledge, skills, and/or abilities required. 

• Minimum 5 years experience in quality and regulatory management in a manufacturing environment.
• Minimum 5 years experience with FDA QSR.
• Demonstrated skills in planning and project management directed toward achievement of business goals.
• Analytical and systematic and well structures, pragmatic way of working.
• Demonstrates a positive proactive approach to problem solving and mentors others to understand and model this approach.
• Demonstrated skills in developing, coaching and training others in an organizational setting.
• Team player and can lead the team or participate as member of team as required.
• Travel as required.
• Technically competent and has IT skills on Microsoft suite products.
• Excellent communication skills

Special Training Preferred:

• FDA QSR / ISO-13485 Compliance
• FDA, MDSAP and Internal Audits

Education and/or Experience.  Include the education and/or experience that is necessary to perform the job satisfactorily.

• BS in science or engineering with 5+ years’ experience in Quality, Manufacturing, Engineering or related field
• Or 4 year degree with 10 years experience in Medical Device or Pharmaceutical industry

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
                                                                                                                                                               
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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.